Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study
| Status: | Recruiting |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 9/9/2018 |
| Start Date: | September 2008 |
| End Date: | December 2021 |
| Contact: | Albert P Garcia-Romeu, PhD |
| Email: | AGarci33@jhmi.edu |
| Phone: | 4105501972 |
One of the most promising lines of investigation for the therapeutic use of hallucinogens in
the 1960s and 1970s was in the treatment of drug dependence. We propose to examine psilocybin
administration combined with a structured smoking cessation treatment program in nicotine
dependent individuals in order to provide preliminary data on the efficacy of this combined
treatment for smoking cessation. Prior work in our laboratory has shown that under carefully
prepared and supportive conditions, psilocybin administration can facilitate highly salient
experiences with enduring personal meaning and spiritual significance (Griffiths et al.,
2006, 2008). It is plausible that embedding such highly meaningful experiences into a drug
dependence cessation attempt may provide an enduring motivation for remaining abstinent.
Cigarette smoking is a good model system for studying drug dependence because users are less
likely to be challenged by the many social and economic impairments that often accompany
dependence on other drugs such as cocaine, heroin, or alcohol. More specifically, we propose
to conduct a randomized controlled comparative efficacy study in which either psilocybin or
transdermal nicotine patch are administered under highly supportive conditions to individuals
who are nicotine-dependent cigarette smokers, who have had multiple unsuccessful quit
attempts, and who continue to desire to quit smoking. Other than nicotine dependence,
participants will be healthy. Fifteen participants have already completed a preliminary
open-label pilot-study with no control condition. Eighty additional participants will be
enrolled and randomized to either psilocybin (n=40), or nicotine patch (n=40) treatment.
Participants will receive a 13-week course of cognitive behavioral therapy for smoking
cessation, with Target Quit Date set for week 5. After several preparation meetings with
study monitors, participants will have either a single day-long psilocybin session using a
high dose (30 mg/70 kg), or a standard 8 to 10-week course of nicotine patch treatment.
Participant smoking status will be assessed repeatedly for 8 weeks after the Target Quit
Date, including biological verification of smoking status through breath and urine samples.
Smoking status will also be assessed at three follow up sessions approximately 3, 6, and 12
months after the Target Quit Date. Additionally, 50 of these participants (25 per treatment
condition) will undergo MRI scanning before and after Target Quit Date to assess the
brain-based mechanisms associated with these treatments. Individuals assigned to the nicotine
patch study treatment condition will be eligible to undergo an optional high dose psilocybin
session after completing the 6-month follow-up meeting.
the 1960s and 1970s was in the treatment of drug dependence. We propose to examine psilocybin
administration combined with a structured smoking cessation treatment program in nicotine
dependent individuals in order to provide preliminary data on the efficacy of this combined
treatment for smoking cessation. Prior work in our laboratory has shown that under carefully
prepared and supportive conditions, psilocybin administration can facilitate highly salient
experiences with enduring personal meaning and spiritual significance (Griffiths et al.,
2006, 2008). It is plausible that embedding such highly meaningful experiences into a drug
dependence cessation attempt may provide an enduring motivation for remaining abstinent.
Cigarette smoking is a good model system for studying drug dependence because users are less
likely to be challenged by the many social and economic impairments that often accompany
dependence on other drugs such as cocaine, heroin, or alcohol. More specifically, we propose
to conduct a randomized controlled comparative efficacy study in which either psilocybin or
transdermal nicotine patch are administered under highly supportive conditions to individuals
who are nicotine-dependent cigarette smokers, who have had multiple unsuccessful quit
attempts, and who continue to desire to quit smoking. Other than nicotine dependence,
participants will be healthy. Fifteen participants have already completed a preliminary
open-label pilot-study with no control condition. Eighty additional participants will be
enrolled and randomized to either psilocybin (n=40), or nicotine patch (n=40) treatment.
Participants will receive a 13-week course of cognitive behavioral therapy for smoking
cessation, with Target Quit Date set for week 5. After several preparation meetings with
study monitors, participants will have either a single day-long psilocybin session using a
high dose (30 mg/70 kg), or a standard 8 to 10-week course of nicotine patch treatment.
Participant smoking status will be assessed repeatedly for 8 weeks after the Target Quit
Date, including biological verification of smoking status through breath and urine samples.
Smoking status will also be assessed at three follow up sessions approximately 3, 6, and 12
months after the Target Quit Date. Additionally, 50 of these participants (25 per treatment
condition) will undergo MRI scanning before and after Target Quit Date to assess the
brain-based mechanisms associated with these treatments. Individuals assigned to the nicotine
patch study treatment condition will be eligible to undergo an optional high dose psilocybin
session after completing the 6-month follow-up meeting.
Inclusion Criteria:
- 21 to 65 years old.
- Have given written informed consent.
- Have a high school level of education.
- Be a daily smoker with multiple unsuccessful previous quit attempts, and report a
continued desire to quit smoking.
- Agree to abstain from smoking and alcohol for 24-hours, and caffeine for 12-hours
prior to MRI scanning (for MRI participants only).
- Agree to abstain from smoking for the psilocybin session from 1 hour before psilocybin
administration until at least 30 hours afterwards.
- Agree to consume approximately the same amount of caffeine-containing beverage (e.g.,
coffee, tea) that he/she consumes on a usual morning, before arriving at the research
unit on the morning of drug session day. If the volunteer does not routinely consume
caffeinated beverages, he or she must agree not to do so on session day.
- Agree to refrain from using any psychoactive drugs, including alcoholic beverages,
within 24 hours of psilocybin administration. Exceptions include caffeine and
nicotine.
- Be healthy as determined by screening for medical problems via a personal interview, a
medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine
medical blood and urinalysis laboratory tests.
Exclusion Criteria:
- Women who are pregnant (positive pregnancy test) or nursing, or are not practicing an
effective means of birth control
- Cardiovascular conditions: uncontrolled hypertension, angina, a clinically significant
ECG abnormality (e.g., atrial fibrilation), TIA in the last 6 months stroke,
peripheral or pulmonary vascular disease
- Epilepsy with history of seizures
- Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of
hypoglycemia
- Currently taking psychoactive prescription medication on a regular basis
- Currently taking on a regular (e.g., daily) basis any medications having a primary
centrally-acting pharmacological effect on serotonin neurons or medications that are
MAO inhibitors. For individuals who have intermittent or PRN use of such medications,
psilocybin sessions will not be conducted until at least 5 half-lives of the agent
have elapsed after the last dose.
- Have HIV or Syphilis.
- Have any current neurological illnesses including, but not limited to, seizure
disorders, frequent migraines or on prophylaxis, multiple sclerosis, movement
disorders, history of significant head trauma, or CNS tumor.
- Morbidly obese, or severely underweight as determined by medical examination.
- Not suitable to undergo an MRI session due to certain implanted devices (cardiac
pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or
other implanted metal parts), body morphology, or claustrophobia (for MRI participants
only).
- Current or past history of meeting DSM-IV criteria for Schizophrenia, Psychotic
Disorder (unless substance-induced or due to a medical condition), or Bipolar I or II
Disorder.
- Current or past history within the last 5 years of meeting DSM-IV criteria for alcohol
or drug dependence (excluding caffeine and nicotine) or severe major depression.
- Have a first or second degree relative with schizophrenia, psychotic disorder (unless
substance induced or due to a medical condition), or bipolar I or II disorder.
- Currently meets DSM-IV criteria for Dissociative Disorder, Anorexia Nervosa, Bulimia
Nervosa, Major Depression, or Post-traumatic Stress Disorder.
We found this trial at
2
sites
Baltimore, Maryland 21224
Principal Investigator: Matthew W Johnson, PhD
Phone: 410-550-1972
Click here to add this to my saved trials
Baltimore, Maryland 21224
Principal Investigator: Elliot Stein, PhD
Phone: 443-740-2782
Click here to add this to my saved trials